This website uses cookies to store information on your computer. Some of these cookies are used for visitor analysis, others are essential to making our site function properly and improve the user experience. By using this site, you consent to the placement of these cookies. Click Accept to consent and dismiss this message or Deny to leave this website. Read our Privacy Statement for more.
Print Page   |   Contact Us   |   Sign In   |   Register
Community Search
WCBP 2016: Round Table Notes
Share |

Below you will find links to notes taken during the Round Table session at WCBP 2016.  

If you have questions regarding the links, please contact Project Coordinator Anna Lingel (alingel@casss.org).

 

 

   
Table 1 - Comparability Issues in Biological Products in Regards to Changes in
Critical Raw Materials, Process and Assay
Click Here 
Table 2 - Control and Characterization of Biotherapeutic Glycosylation and Other PTMs Click Here
Table 3 - Implications of Product Specific Monographs for Biotherapeutic Products Click Here
Table 4 - Forced Degradation Studies: Best Practices & Strategies Click Here 
Table 5 - Potency Assays: Cell Based vs. Non Cell Based Formats Click Here
Table 6 - The Holy Grail: Global Specifications Click Here
Table 7 - Trends in Regulatory Inspections and Best Practices Click Here 
Table 8 - Accelerated Development (Global Considerations) Click Here
Table 9 -  Characterization of Complex Vaccines Click Here
Table 10 - Accelerating Late-Stage Development Not Available 
Table 11 - CMC Challenges for Breakthrough Programs Click Here
Table 12 - Biosimilars Click Here
Table 13 - Biologics Process Control Click Here 
Table 14 - Setting Phase Appropriate Specifications  Click Here
Table 15 - Identity Testing to Support Lot Release Click Here
Table 16 - Raw Material Testing - Enough is Enough! Or is it? Click Here 
Table 17 - Control and Characterization of Host Cell Proteins and Residual DNA Not Available 
Table 18 - Low Endotoxin Recovery Click Here
Table 19 - Lessons Learned from QbD Click Here
Table 20 - Blood Analytics Not Available 
Table 21 - Structure/Function Characterization Click Here 
Table 22 - Developing Bi-specifics Click Here
Table 23 - Biopharmaceutical Knowledge and Data Management   Click Here
Table 24 - Small Company Concerns Click Here
Table 25 - Use of Public and Proprietary Databases when Characterizing
Host Cell Proteins with Mass Spectrometry
Click Here 
Table 26 - Oligonucleotide Therapeutics and mRNA Click Here 
Table 27 - Control Strategies for Personalized Medicines  Click Here
Table 28 - Disposable Technologies Click Here
Table 29 - Multi-Attribute Methods Click Here
Table 30 - The Voyage of the BLA Click Here
Table 31 - How do you Define Ranges for Specifications and Comparability for
Glycosylation Attributes in the Midst of Micro-heterogeneity?
Not Available 
Table 32 - Viral Clearance and the Use of Advanced Technologies Such as NGS
in the Detection of Adventitious Agents in Biologics
Click Here
Table 33 - New Product Introduction (NPI) Strategies at CMOs Click Here 
Table 34 - Legacy Products and the Implementation of QbD Click Here 
Table 35 - Analytical Challenges Related to Antibody Drug Conjugates
Characterization and Specifications
Click Here
Table 36 - Validation of Rapid Microbiology Methods Not Available
Table 37 - Updating Compendial Methods and Biosimilars Not Available 
Table 38 - How to Characterize Polyclonal Products for Infectious Diseases Click Here 

 


 

 

 

more Calendar

1/28/2019 » 1/31/2019
CMC Strategy Forum and WCBP 2019

1/29/2019 » 1/31/2019
WCBP 2019 Live Stream

3/12/2019 » 3/13/2019
CMC Strategy Forum Latin America 2019

Featured Members
William Weiss, Eli Lilly and CompanyFind out more about Will in this month's Member Spotlight!

Membership Software Powered by YourMembership  ::  Legal